MARLBOROUGH, Mass., Feb. 25, 2021 /PRNewswire/ -- CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), announced today that results from its HeartLight® X3 Pivotal Study were published in the premier journal Circulation: Arrhythmia and Electrophysiology (CircEP), which features articles related to research in and the practice of clinical cardiac electrophysiology and the diagnosis and management of cardiac arrhythmias.
The published results, which were posted to the journal's website on February 11, 2021, showed that all endpoints of the pivotal study were achieved, demonstrating significantly faster pulmonary vein isolation (PVI) ablation and procedures times with the HeartLight X3 System compared to the previous generation system, the HeartLight Endoscopic Ablation System, and with comparable safety and efficacy1.
A key differentiator for the HeartLight X3 System is the ability for the electrophysiologist (EP) to visualize the PVI procedure, something no other cardiac ablation technology can provide. This direct visualization combined with the universally compliant Excalibur BalloonTM allows the EP to achieve stable, effective contact with the pulmonary vein, which is key to preparing the precise delivery of energy in the PVI procedure. This visualization combined with the HeartLight X3 System's RAPID mode, which enables uninterrupted, high-speed, circumferential lesion creation, was shown in this pivotal study to drastically decrease ablation and procedure times compared to the conventional HeartLight System.
HeartLight X3 Pivotal Study Data Highlights:
- The primary endpoint was to test whether ablation time with the HeartLight X3 system was less than the ablation time with the current HeartLight system. Results from this study showed the ablation time was significantly shorter with the X3 than the original HeartLight device (77.3 ± 25.8 min versus 173.8 ± 46.6 min; p<0.0001). Ablation time included a 30-minute post-ablation waiting period.
- The secondary acute endpoint was looking at procedure time which was significantly shorter with X3 then the original HeartLight device (103.7 ± 32.3 min versus 236.0 ± 52.8min; p<0.0001). Additionally, fluoroscopy time was significantly shorter with the new X3 device (6.9 ± 3.5 versus 35.6 ± 18.2; p<0.0001).
- The HeartLight X3 system also showed improvement in chronic effectiveness at both 6 and 12 months. Freedom from symptomatic AFib reported at 6 months was 89.5 percent versus 75 percent and 71.9 percent versus 61.1 percent at 12 months, for HeartLight X3 and conventional HeartLight, respectively.
More than 33 million patients worldwide suffer from AFib,2 which has been associated with significant symptoms, functional impairment, stroke, cognitive decline, heart failure, and reduced longevity.
About the HeartLight X3 System
The U.S. Food and Drug Administration (FDA) approved the next-generation HeartLight X3 System in May 20203. This third generation HeartLight X3 System offers a unique RAPID mode, which includes precise motor control that enables uninterrupted, high-speed, circumferential lesion creation under direct visual control of the physician. These pivotal study endpoints reveal that the new HeartLight X3 system shows significant improvements over the original HeartLight system.
About CardioFocus, Inc.
Founded in 1990 and headquartered in Marlborough, MA, CardioFocus is a medical device innovator and manufacturer dedicated to advancing ablation treatment for cardiac disorders such as atrial fibrillation (AFib), the most common heart arrhythmia. The HeartLight balloon catheter, endoscope, sheath, console and balloon fill media are all manufactured in the USA. For more information, visit http://www.CardioFocus.com.
1 Schmidt, Boris, et al. Pivotal Study of a Novel Motor Driven Endoscopic Ablation System. Circulation: Arrhythmia and Electrophysiology, 2021, doi:10.1161/circep.120.009544.
2 Chugh SS, Havmoeller R, Narayanan K, et al.; Worldwide Epidemiology of Atrial Fibrillation: A Global Burden of Disease 2010 Study. Circulation. 2014 Feb 25;129(8):837-47.
3 The HeartLight Endoscopic Ablation System is indicated for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation.
SOURCE CardioFocus, Inc.